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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K170870
Device Name Site~Rite Halcyon Diagnostic Ultrasound System
Applicant
Chison Medical Imaging Co., Ltd.
#228, Changjiang E. Rd.,Block 51 And 53
Phase 5 Industrial Park, Shuofa
Wuxi,  CN 214142
Applicant Contact Qifei Liu
Correspondent
Chison Medical Imaging Co., Ltd.
#228, Changjiang E. Rd.,Block 51 And 53
Phase 5 Industrial Park, Shuofa
Wuxi,  CN 214142
Correspondent Contact Qifei Liu
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/23/2017
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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